Microbiologist II (Non-Sterile)

The Microbiologist duties and functions include the manufacture, testing and quality control of materials and/or products.About the RoleEssential Responsibilities include performing and resulting routine testing on samples in a timely manner independently, with minimal supervision, to meet assigned testing deadlines.ResponsibilitiesBe able to interpret results to determine pass or fail.Record, report and investigate unexpected test results.Manufacturing and quality control testing for in-house media production.Ability to perform and train staff in complex testing with minimal supervision.Aseptic production of BSL-1 and BSL-2 microbial stocks.Lead the microbiology staff in the execution of special projects, as needed.Be able to research and modify methods, when applicable, during method suitability or development.Handle and maintain BSL-2 regulated microorganisms.Complies with company policies and all applicable SOPs; complies with ISO 17025, BSL-2, cGMPs, cGLPs A2LA requirements and Quality Control Guidelines.Perform standard operation maintenance and minimal troubleshooting of assigned equipment and systems to confirm equipment is operational prior to use.Notify supervisor and engineering promptly of calibration failures and repair needs if equipment is not within operational compliance.Assist in ensuring compliance with all Standard Operating Procedures (SOPs), SOPs are accurate, up-to-date, and parallel to all required regulatory documents.Participate in cross technology educational program within the laboratory to learn all laboratory functions.Maintain familiarity with use of all applicable equipment, systems, and procedures (SOPs).Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment and system troubleshooting, and microbiology/taxonomy issues.Provide technical assistance and back-up support in all laboratory workstations as required.Maintain current and accurate documentation.Assist in revising and reviewing SOPs in a timely manner as required.Assist with laboratory compliance audits and laboratory safety audits.Maintain clean, orderly, and safe laboratory work area; assist with safety training.Perform more complex testing on samples (method suitability modifications, method development, etc.).Support supervisor or project microbiologists in validation activities as assigned.Accurately identify, monitor, and report microbiological trends.Train microbiology staff.Participate in technical discussions internally or with clients, when applicable.Performs all other duties as required.QualificationsBachelor’s degree in microbiology or related science field, including at least 12 semester hours of hands-on laboratory courses in microbiology and/or chemistry.MS or Minimum 3 years of pharmaceutical/biochemical QC laboratory experience in a microbiology setting.Demonstrated relevant experience in a microbiology laboratory (Q.C., pharmaceutical, biotech or clinical lab experience preferred), where one or more of the following functions was successfully performed: microbial enumeration testing, growth promotion testing, streak for isolation, testing with microorganisms, environmental monitoring, method suitability, microbial identification, gram staining, pipetting small volumes, SOP/documentation revisions, or other applicable testing/skills.Required SkillsExcellent analytical, decision making and interpersonal skills.Excellent verbal and written communication skills.Excellent working knowledge and understanding of microbiology principles and methods and the ability to communicate this information to others.Ability to multitask within a single task and multiple tasks when applicable.Ability to solve routine and non-routine laboratory issues/problems.Physical dexterity to perform testing accurately and precisely.Ability to read, understand and comply with Company policies and SOPs, including safety rules and regulations.Ability to work independently, with minimal supervision as well as work within a team to achieve the same goal.Intermediate level computer skills in Microsoft Office, Word, Excel, Outlook, and PowerPoint.Ability to adapt, learn, and teach new skills as needed.